Dettagli per singolo studio

DEC-NET Serial number FR505

Published online	06/07/2006 15.01.00
Last updated	06/07/2006 16.13.46

Other protocol ID number	INOT - 27
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	CHRONIC RESPIRATORY DISEASE ARISING IN THE PERINAT
Experimental drug
Nitric Oxide for inhalation Treatment regimen (dosage and duration) Patients will be receive treatment gas (NO at 5 ppm or an equivalent volume of N2 placebo) for a minimum of 7 days, and a maximum of 21 days. Patients who require less than 7 days of assited ventilation may complete the minimum duration of therapy via face mask or nasal cannula. Patients will otherwise remain on study treatment as long as respiratory support is required, or until 21 days of therapy have been completed. Placebo consisting of 100% Grade 5 Nitrogen (N2) gas will be administered in amanner identical to that of the active treatment.
Gender	Both
Age (range)	24 - 28 +(6d) weeks GA
Eligibility criteria
Inclusion criteria
- Inborn preterm infants 24 - 28 + 6(days) weeks gestational age (defined by first trimester ultrasound or if not available based on the last menstrual period) who requires the use of surfactant within 12 hours of birth (either prophylactically, - or for signs of developing respiratory distress), or who requires the use of CPAP FIO2 > 30% on mean airway pressure > 4 cm H2O) within 12 hours of birth in order to maintain an SpO2 >= 85%. - Informed consent of the parent or legal guardian
Exclusion criteria
- Outborn infants. - Infants >= 29 weeks gestational age. - Infants with birth weight < 500 grams. - Infants requiring FiO2 > 0.5 to maintain SpO2 > 85%, on a sufficient mean airway pressure in order to achieve adequate chest inflation two hours after the proper administration of exogenous surfactant. - Any suspected congenital heart disease other than patent ductus arteriosus or artial septal defect. - Any infant with suspected lung hypoplasia associated with congenital diaphragmatic hernia. - Any infant with severe bleeding or coagulation abnormalities at high risk of diathesis. - Any infant in whom a decision has been made not to provide full treatment, eg., chromosomal abnormalities , severe multiple abnormalities, severe birth asphyxia, etc. - Use of another investigational drug or decice before or during the active study period.
Trial design/methodology
Phase	3
Kind of study	Efficacy Prophylaxis
Design	Controlled Randomised Blinded Double blind
Purpose of study
Primary objective : To assess the safety and efficacy of inhaled nitric oxide to reduce the risk of death or chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow up. Secondary objectives are to assess : -number of days of assisted ventilation. -lenght of hospitalization. -total number of days in-hospital from 36 weeks gestational age (GA) to one year and two years corrected age. -Average number of days in-hospital for respiratory illness from 36 weeks GA to one year and two years corrected age.
Primary outcomes
Assessment at 36 week post-menstrual age (PMA). An infant who is alive without Chronic Lung Disease (CLD) at 36 PMA will be counted as a "success". An infant who has died, or who has CLD at 36 weeks PMA will be counted as a "failure".
Secondary outcomes
- Number of days of assisted ventilation. - Lenght of hospitalisation - Total number and average number of days in-hospital from 36 weeks gestational age (GA) to one year and two years corrected age.
Summary of study design, objectives, and ongoing research findings
Prospective, multicentre, double-blind, placebo-controlled, randomized study assess the safety and efficacy of inhaled nitric oxide to reduce the risk of death or chronic lung disease (as defined by the need for supplemental oxygen at 36 weeks post menstrual age) in pre-term infants with respiratory distress, and evaluate the long-term effects of the therapy on the development of these children over 7 years of clinical follow up. Nitric Oxide for inhalation (NO or an equivalent volume of N2 [placebo]) at 5 ppm will be administrered continuously for a minimum of 7 days, and a maximum of 21 days in mechanically ventilated patients. The primary outcome is assessed at 36 week post-menstrual age (PMA). An infant who is alive without Chronic Lung Disease (CLD) at 36 PMA will be counted as a "success". An infant who has died, or who has CLD at 36 weeks PMA will be counted as a "failure".